SKIN MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL

Dosage form: lotion
Ingredients: DIMETHICONE 1.2500mL in 100mL
Labeler: APOLLO HEALTH AND BEAUTY CARE
NDC Code: 63148-320

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

BACK LABEL - DRUG FACTS BOX

ACTIVE INGREDIENT

DIMETHICONE 1.25% (SKIN PROTECTANT)

WARNING

FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

USES AND DIRECTIONS
  • USES: HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN.
  • DIRECTIONS: APPLY AS NEEDED.

FRONT AND BACK LABELS

12OZ FRONT AND BACK LABELS: dgb12.jpg

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

SKIN MOISTURIZING   WITH NATURAL COLLOIDAL OATMEAL
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-320
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1.2500 mL  in 100 mL
Packaging
#Item CodePackage Description
1NDC:63148-320-12355 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/25/2010
Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)

Revised: 06/2010
 
APOLLO HEALTH AND BEAUTY CARE

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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